Hybrid AF -- A Prospective Registry

Hybrid Procedure for the Treatment of Long Standing Persistent Atrial Fibrillation - A Prospective Registry

Atrial Fibrillation (AF) is a form of rapid irregular heart rhythm that starts in the upper chambers of the heart (called atria) and is often associated with many health problems. It can cause stroke, palpitations and heart failure. The management of long standing (chronic) AF may require additional medications and blood thinners, potentially for life. It may also require procedures where the heart is shocked with an electrical current to restore normal rhythm. Some patients require a procedure called radiofrequency ablation to address the arrhythmia.

The purpose of this registry is to collect information on patients undergoing this combination of procedures into a database, and to then use this information for scientific study to improve the treatment of atrial fibrillation.

Study Overview

• Status: Withdrawn
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Standard of Care

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing standard of care procedures to treat Atrial Fibrillation at the University of Kansas Hospital

Description

Inclusion Criteria:

• Documented effectiveness failure of at least one Vaughan-Williams Class III AAD
• Persistent AF as defined by the HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation
• Absence of significant structural heart disease as demonstrated by a transthoracic echocardiogram (TTE) of all four chambers of the heart, computed tomography (CT) scan or magnetic resonance imaging (MRI) scan within 6 months prior to enrollment
• Absence of left atrial thrombus as documented by an imaging study (e.g., TTE, transesophageal echocardiogram (TEE), thoracic CT scan, MRI, or left atrial angiography) within 30 days prior to procedure

Exclusion Criteria:

• History of longstanding persistent AF for more than 3 years
• Documented left atrial size of 60 mm or more
• Documented left ventricular ejection fraction (LVEF) less than 40%
• History of cerebrovascular disease, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment
• Significant underlying structural heart disease requiring surgical or procedural intervention within the last six months of initial procedure
• Known contraindication to anticoagulant therapy, or inability to comply with anticoagulant therapy
• Other clinical conditions precluding inclusion (e.g., organ disease, disturbances of hemostasis, etc.)
• Pregnancy, planned pregnancy (females of childbearing potential must have a negative pregnancy test prior to enrollment and agree not to become pregnant during the trial) or breastfeeding;
• Concomitant procedure planned

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Atrial Fibrillation; Patients with Atrial Fibrillation that undergo standard of care procedure at the University of Kansas Hospital	Procedure: Standard of Care; Standard of care procedure as determined by treating physician for Atrial Fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Outcomes of patients with persistent Atrial Fibrillation who undergo the standard of care hybrid procedure	2 years

Collaborators and Investigators

• Sponsor: Dhanunjaya Lakkireddy, MD, FACC
• Collaborators: Estech
• Investigators: Principal Investigator: Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: July 5, 2012
• First Submitted That Met QC Criteria: July 5, 2012
• First Posted (Estimate): July 10, 2012

Study Record Updates

• Last Update Posted (Estimate): April 22, 2015
• Last Update Submitted That Met QC Criteria: April 20, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 13117